# K052941: I-Neb Insight Aad System

- Pathway: 510(k) (Special)
- Applicant: Profile Therapeutics Plc
- Decided: Dec 9, 2005 after 50 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K072019: AKITA2 Apixneb (2007), 3 descendants of its own
- K142059: Fox Mobile (2015), 0 descendants of its own
- K102454: I-Neb Aad System with Tim; I-Neb Insight Aad System (2011), 0 descendants of its own
- K090730: Akita Jet (2009), 0 descendants of its own

## Indications for use
The intended purpose of the I-neb Insight AAD System is that is it is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize liquid medication approved for use with the I-neb AAD System for inhalation by the patient in the home care, nursing home, sub-acute institution, or hospital environment.

Source page: https://510kreport.com/device/K052941
Methodology: https://510kreport.com/methodology